Medical connector

ABSTRACT

Disclosed is a connector for introducing medication into a patient in a safe, convenient way. It comprises a pair of plastic tubular members adapted to be manually pushed together to engage in a male-female relationship, and a locking mechanism that detachably secures the members together. The male member has a sealed entry port at its end, and the female member safely houses within it a needle which centrally pierces the seal of the port upon engagement of the members. Preferably, the locking mechanism provides a &#34;click&#34; sound when it locks the members together.

RELATED PATENT APPLICATIONS

This application is a continuation of application Ser. No. 07/346,193,filed Jan. 9, 1987, now abandoned, which was a division of applicationSer. No. 06/606,679, filed May 3, 1984, now abandoned, which is acontinuation-in-part application of U.S. patent application Ser. No.06/543,248, filed Oct. 19, 1983, abandoned and entitled "MedicalConnector System," which was a continuation-in-part application of U.S.patent application Ser. No. 06/460,585, filed Jan. 24, 1983, andentitled "Device for Intravenously Introducing Medication Into aPatient," (now abandoned). These previously filed patent applications,which are incorporated herein by reference and made part of this patentapplication, disclose the experimental versions of this invention. Theseexperimental versions are also disclosed herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to medical connectors used in the treatment ofthe injured or sick, and in particular to a connector for introducingmedication into a patient in a safe, convenient way.

2. Background Discussion

It is a common practice in treating patients, particularly patients whomust be cared for under emergency conditions, with medication introducedinto the patient intravenously. An intravenous solution, commonlyreferred to as parenteral liquid, is fed from a container holding thisliquid. The liquid flows through tubing into a needle which has beeninserted into the patient's vein. The needle is taped securely to thepatient's body and is not likely to pull loose if the patient moves.Medication needed to sustain the life of the patient, for example, drugswhich maintain the blood pressure of the patient at the desired level,are added to the parenteral liquid. The conventional practice is tointroduce the medication through a second needle inserted into a sealedentry port in the tubing through which the parenteral liquid flows.

One problem with this conventional practice is that the needle may bepulled loose from the sealed port relatively easily. Such accidentalremoval of the needle from the sealed port can have very seriousconsequences and could even lead to the death of the patient. Althoughmany hospitals require nurses to tape the needle securely to the tubing,this is not always done, because taping is a burdensome and timeconsuming task.

A second problem with the conventional practice is needle sticks. Fromtime to time a nurse is attempting to insert the needle into the sealedentry port will accidentally stick himself or herself with the needle.This often occurs under emergency conditions when the nurse is underpressure to complete this task as quickly as possible. Not only is theaccomplishment of the task delayed, but the nurse must stop working andhave a blood test performed. Such a test is needed in case the nursebecomes infected, because the hospital will be responsible financially.Consequently, needle sticks not only result in increased hospital cost,but are a possible life treating event to the nurse.

A third problem with the conventional practice is infection. All toooften a patient's life is seriously endangered by bacteria gaining entryinto a patient's blood stream and infecting the patient. In a vastnumber of cases it is unknown how the bacteria gain entry. We haveobserved conditions in hospitals and identified that one likely way thebacteria gain entry is by contamination of the needle inserted into thesealed entry port. This happens when the nurse notices that the needlehas been pulled loose and simply reinserts it even though it may nowhave on its surface bacteria picked up by direct contact with, forexample, the patient's bedding. Another possible way that bacteria maygain entry into the patient's blood steam is through contamination ofthe tape used to hold the needle to the connector.

MAJOR FEATURES OF THE INVENTION

The problems discussed above present a serious health hazard to patientsand their nurses. The present invention eliminates these problems andprovides a medical connector which is both safe and convenient to use.

There are several features of this invention which contribute to itssafety and convenience, no single one of which is solely responsible forthese desirable attributes. Many of these features were present in ourexperimental versions of the invention, which were improved aftertesting. Without limiting the scope of this invention as expressed bythe claims, its more prominent features will now be discussed briefly.After considering this discussion, and particularly after reading thesection of this application entitled DETAILED DESCRIPTION OF THEDRAWING, one will understand how the features of this invention providethe attributes of safey and convenience.

One safety feature of this invention is the use of a cap member toenclose the needle to be inserted into the sealed entry port structure.This cap member fits snugly over the entry port structure, connectingwith the port structure in a male-female mating relationship. The needlepierces the seal when the cap member is seated on the port structure.This needle is housed deep within a cavity in the cap member thatterminates in an open mouth into which the sealed end of the portstructure fits. This open mouth is narrow in width so that the finger ofthe nurse or patient cannot fit into the cavity and contact the needle.Since the needle is so mounted within the cap member, the likelihood ofbacterial contamination is avoided or reduced and the nurse is protectedagainst accidental needle sticks.

A second safety feature is provided by the wall design of the cap memberand port structure. These walls are of preferably cylindricalconfiguration and engage each other like a telescope. The interiorsurface of the wall of the cap member slides over the exterior surfaceof the wall of the mating port structure, with these walls engaging eachother to guide the needle into the center of the seal. This ensures thatthe needle does not scrape against the inside surface of the wall of theport structure. Particles scraped from this wall could make their wayinto the patient's blood stream and result in death. This potentiallylethal condition is inherent in the design of conventional devices. Butthe connector of this invention, with the guideway wall design of thecap member and port structure, ensures that the needle is directed intothe center of the seal so that it avoids scraping against the insidesurface of the wall of the port structure. This guideway wall designalso permits the nurse quickly to connect the cap member to the portstructure. This makes the connector of this invention not only moreconvenient to use, but in emergencies, enables the nurse to administermedication to a patient faster than with conventional devices and doingit without the danger of needle sticks.

A third safety feature of the invention is that a locking mechanismdetachably secures the cap member to the port structure. Because of thisfeature, movement of the patient does not result in accidental removalof the needle from the seal. Although many different types of lockingmechanisms may be employed, the preferred one provides a sound uponlocking engagement of the cap member and port structure. We have devisedsuch a locking mechanism which produces a sound such as a "click." This"click" is an audible signal which tells the nurse that the cap memberis locked safely to the port structure and cannot be accidentally jarredloose by movement of the patient.

Several embodiments of the invention illustrating all the features ofthis invention will now be discussed in detail. These embodiments showthe invention being used for administering medication intravenously to apatient. This invention may also be used to administer medication to apatient in other ways, for example, intracranially or intraperitonially.

BRIEF DESCRIPTION OF THE DRAWING

The drawing, wherein like numerals indicate like parts, depicts fourembodiments of this invention in which:

FIG. 1 is a schematic view illustrating administering medicationintravenously to a patient in accordance with conventional practice.

FIG. 2 is a cross-sectional view of a piggyback connector forintroducing parenteral liquid and medication intravenously to thepatient shown in FIG. 1.

FIG. 3 is a perspective view of the first embodiment of the medicalconnector of the present invention which employs a slip-on/twist locktype means for securing the cap member to the port structure.

FIG. 4 is a cross-sectional view of the connector shown in FIG. 3 takenalong line 4--4 of FIG. 3.

FIG. 4a is a perspective view showing how the cap member prevents needlesticks.

FIG. 5 is a perspective view of the second embodiment of the medicalconnector of the the present invention which employs a snap-on typemeans for securing the cap member to the port structure.

FIG. 6 is a cross-sectional view of the connector shown in FIG. 5 takenalong line 6--6 of FIG. 5.

FIG. 7 is an exploded perspective view of the third embodiment of themedical connector of the present invention which employs a snap-on typemeans for securing the cap member to the port structure.

FIG. 8 is a side elevational view, with sections broken away, of theembodiment shown in FIG. 7. In this FIG. 8 the handle of the lockingmechanism attached to the cap member just engages the lip of the portstructure.

FIG. 9 is the same view as shown in FIG. 8, except the handle of thelocking mechanism is flexed and just about to snap into lockingengagement with the lip of the port structure.

FIG. 10 is the same view as shown in FIGS. 8 and 9, except the handle ofthe locking mechanism is now engaging the lip of the port structure inthe locking position.

FIG. 10a is the same view as shown in FIGS. 8, 9 and 10, except thehandle of the locking mechanism is flexed to permit removal of the capmember from the port structure.

FIG. 11 is a top plan view of the cap member.

FIG. 12 is a bottom view of the handle of the locking mechanism shown inFIGS. 8 through 11.

FIG. 13 is a side elevational view of the handle of the lockingmechanism.

FIG. 14 is a side elevational view of the cap member with the handle ofthe locking mechanism removed.

FIG. 15 is a top plan view of the cap member with the handle of thelocking mechanism removed.

FIG. 16 is an enlarged cross-sectional view of a portion of the hinge ofthe locking mechanism.

FIG. 17 is an enlarged cross-sectional view of the position of thehandle just prior to being secured to the cap member.

FIG. 18 is a cross-sectional view similar to that shown in FIG. 17depicting the handle coupled to the cap member.

FIG. 19 is a cross-sectional view taken along line 19--19 of FIG. 18.

FIG. 20 is a perspective view showing the medical connector of FIG. 7having one end coupled to a tube extending from a patient's arm andanother end coupled to a tube extending from a container holdingmedication.

FIG. 21 is a perspective view of a medical connector like that shown inFIG. 7, except the port structure has the lip which engages the handleof the locking mechanism as an integral part of a conventional piggybackconnector.

FIG. 22 is a schematic view showing a medical connector of the typeshown in FIG. 7 designed to introduce medication into a patient's chest.

FIG. 23 is a perspective view of a fourth embodiment of the medicalconnector of this invention which employs a slip-on/twist lock typemeans for securing the cap member to the port structure.

FIG. 24 is an enlarged cross-sectional view taken along line 24--24 ofFIG. 23, showing the cap member being connected to the sealed entry portstructure.

DETAILED DESCRIPTION OF THE DRAWING Conventional Connector System

As shown in FIGS. 1 and 2, the current way of intravenously introducingparenteral liquid into a patient is by the conventional feeding system10. This feeding system 10 includes a container 12 for the parenteralliquid, a tube 14 extending from the container and connected to a Y or"piggyback" connector 16, and a tube 18 from the piggyback connector toa needle (not shown) inserted into a vein of the patient. The needle istaped to the patient so that movement of the patient will not result inthe needle being pulled from the patient's vein.

As best illustrated in FIG. 2, medication from the container 20 isintroduced through the piggyback connector 16 into the parenteral liquidflowing through the feeding system 10. This piggyback connector 16consists of two tubular conduits 22 and 24 which merge into a thirdtubular conduit 26. The tubing 14 from the container 12 of parenteralliquid is inserted into the inlet port 28 of the conduit 22 and securedin position, for example, by an adhesive which bonds the externalsurface of this tube to the internal wall surface of the conduit. Thereis a stop 30 which limits the extent to which this tube 14 can beinserted into the conduit. In a similar fashion, the tube 18 is securedto the outlet port 32 of the piggyback connector. This tube 18 isinserted into the outlet port 32 until it abuts a stop 34 in theinternal wall of the conduit. This tube 18 is secured by an adhesive tothe internal wall of the conduit 26.

The sealed entry port structure of the conventional feeding system 10 isprovided by the branch conduit 24 which has a standard latex rubber seal36 at its inlet port 38 to seal this port. Consequently, bacteria cannotenter the piggyback connector 16 via the inlet port 38 because of theseal 36. This seal 36 is of conventional design and includes coaxialannular aprons 40 and 42 which fit over the conduit wall 24a and gripthe external and internal wall surfaces to hold the seal securely to theconduit 24. A suitable seal may be obtained from the West Company ofPhoenixville, Pa.

The medication is introduced into the parenteral liquid flowing throughthe piggyback connector 16 by a needle 44 which is inserted through thecentral part of the seal 36 into the branch conduit 24. This needle 44is connected by a suitable connector 46 to a tube 48 which is connectedto the container 20 (FIG. 1) for the medication. As parenteral liquidflows through the piggyback connector 16 into the inlet port 28 and outthe outlet port 32, the medication is drawn into this stream of liquid,flowing from the container 20 via the tube 48 and through the open tipor end 44a of the needle 44 into the parenteral liquid.

After studying FIGS. 1 and 2, the several problems associated with theconventional practice can now be more fully understood. If the patientmoves, for example, rolls or moves his or her arm, the needle 44 may bepulled from the seal 36. If this occurs, the latex seal 36 hassufficient resiliency to close off the hole in the seal produced by theneedle 44. The parenteral liquid will continue to flow into thepatient's system, but the necessary medication is no longer beingintroduced into it. The consequences of this condition are very graveand, if this condition is unnoticed by the nurse, it could result in thedeath of the patient or serious complications in the patient'streatment. Even if the nurse notices that the needle 44 has been removedfrom the seal 36 and reinserts it into the seal, it is possible that theneedle has been contaminated with bacteria. The use of such acontaminated needle 44 is unacceptable, but nevertheless this sometimeshappens. The needle 44 may be taped to the conduit 24, and manyhospitals instruct nurses to do this. When this task is done, the needle44 is secured, but cannot be conveniently removed and then reinserted.And even when taping the needle 44, if this is not done carefully, theneedle may still be contaminated by the nurse touching the needle or thetape being contaminated. Also, because the nurse holds the conduit 24with one hand while inserting the needle 44, the nurse may accidentallystick the needle directly into the hand holding this conduit, or stickthe needle through the conduit wall 24a into this hand.

These problems associated with the conventional practice are eliminatedby the several different embodiments of this invention disclosedhereinafter.

FIRST EMBODIMENT OF THE INVENTION

As illustrated in FIGS. 3 and 4, the first embodiment of this invention,connector 49, employs a cap member 50 housing deep within the needle 44.As will be discussed in greater detail hereinafter, the cap member 50 issecured by a slip-on/twist lock type of locking mechanism to thepiggyback connector 16 so that movement of the patient does not resultin the needle 44 being pulled from the seal 36. The parenteral liquid isintroduced via the conduit 24, and the conduit 22 carries the seal 36that covers the inlet port 28. In this embodiment, this sealed conduit28 constitutes the entry port structure 27. The cap member 50 isdetachably secured to the entry port structure 27, with the needle 44penetrating the center of the seal 36 when the cap member 50 mates withthe port structure 27.

The cap member 50 comprises a cylindrical connector section 56 having ahollow interior forming the chamber or cavity 52 housing the needle 44.This needle 44 is disposed lengthwise along the longitudinal axis of thecavity 52 and is centrally located. The cavity 52 has an open mouth 52awhich allows the cap member to be seated over the port structure 27. Themouth 52a, however, is constricted so that, as illustrated in FIG. 4a,it prevents the little finger of a typical adult user from beinginserted into the cavity 52. The tip or end 44a of the needle is safelydisplaced inwardly from the open mouth 52a so that even if the userintentionally inserted his or her finger into the open mouth, the tip ofthe needle would not stick this finger. Typically, the open mouth 52ahas a maximum width of no greater than about one centimeter, and theminimum distance between the mouth 52a and the tip 44a is about onecentimeter.

The locking mechanism includes the threads 69a formed in the end 54 ofthe interior cavity wall 55 and the threads 69b in the exterior wall ofthe conduit 22. These threads 69a and 69b engage upon connection of thecap member 50 to the port structure 27 by screwing the cap member to theconduit 22. The top of the cap member 50 has a pair of outwardlyextending wings 58 which facilitate screwing the cap member 50 to theconduit 22. As this is done, the interior wall 55, sliding over theexterior surface of the conduit 22, guides the needle 44 so that itpenetrates the center of the seal 36. To further ensure that the needle44 penetrates the center of the seal 36, the threads 69b could belowered further beneath the seal so that the cap member would fittelescopically over the conduit 22 and then be screwed into position.Thus, the cap member 50, serving as the female component, and conduit22, serving as the male component, mate in a male-female relationship,with the needle 44 always being housed safely within the center of thecavity in an unexposed condition and positioned to pierce the center ofthe seal 36.

A spindle 59 is provided to enable the cap member 50 to be screwed ontothe port structure 27 without twisting the tube 48. This spindle 59 isreceived within an opening 61 within the cap member 50. The body of thespindle 59 has a cylindrical neck section with a groove 63 in an endwhich protrudes from the opening 61. The cylindrical body expandsoutwardly slightly to provide a shoulder 65 which engages a stop 66 whenthe spindle 59 is placed in the opening, and a TRU seal C-ring 67 isreceived in the groove 63 to hold the spindle in position but allowingthe cap member to revolve about the spindle as it is screwed onto theport structure 27.

Along the longitudinal axis of the spindle 59 is a passageway 60. Thetube 48 from the container 20 holding the medication is inserted intothe one end 60a of the passageway 60 and is bonded to the internalsurface of this passageway, for example, by means of an adhesive. Theother end 60b of the passageway terminates in a threaded connectorsection 62 to which the needle 44 is secured. This needle has an adapter64 which has an internal thread which engages the threads of theconnector section 62. The needle 44 extends outwardly from this adapter64. Thus, the needle 44 is held secure to the piggyback connector 16,penetrating the center of the seal 56 with its point 44a safelydisplaced away from the inside wall 55 of the conduit 22.

This connector 49 embodies many of the features of this invention. Forexample, the cap member 50 safely houses the needle 44, and the threadson the guiding walls provide means for detachably securing the capmember to the port structure without taping. But it has severalcomponents, and therefore is costly to manufacture, it is time consumingto screw the cap member 50 to the port structure, and it does notprovide an audible signal when the cap member is safety secured to theport structure. This later feature is provided by the second and thirdembodiments of this invention.

SECOND EMBODIMENT OF THE INVENTION

The second embodiment of the present invention, connector 71, is shownin FIGS. 5 and 6. In this embodiment a cap member 70, similar to capmember 50, is simply snapped onto the piggyback connector 16. Thesnap-on type locking mechanism of this connector 71 is easier to use andless costly to manufacture than the slip-on/twist type of the firstembodiment.

In this embodiment, the cap member 70 includes a hollow cylindricalelement 72 which carries on its exterior two clips 74 which have catchtips 76 that snap into a groove 78 in the external wall of the conduit22. The clips 74 are mounted by hinges 75 to the element 72, and areintegral with the element 72. A plug assembly 80 carries the tubing 48and the needle 44, which is mounted on an adapter 64 such as shown inFIG. 4. This plug assembly 80 is glued or otherwise bonded to the openend of the cylindrical member 72. The cap member 70, including clips 74and hinges 75, are molded from the same material, for example, nylon,which is a material having the desired resiliency.

To attach the cap member 70, one simply slips the member 70 over theconduit 22. The clips 74 bend outwardly slightly and, when the catchtips 76 of the clips are opposite the groove 78, the clips snap in placeas shown in solid lines in FIG. 6. The centrally mounted needle 44 isguided into the center of the seal 36 by the cap member 70, which, likea telescope, slides over the tubular conduit 22. There is shoulder 82which serves as a stop to limit the movement of the cap member 70. Thisshoulder 82 brings the catch tips 76 of the clips into registration withthe groove 78. The hinges 75, being of the same material as the clips74, provide an internal bias or spring action due to the resiliency ofthe material from which these clips and hinges are made. Consequentlythe clips 74 snap into a locking position, locking the cap member to theconduit 22 when the catch tips 76 are in registration with the groove78. To release the cap member from the piggyback connector 16, the clips74 are simply depressed and the cap member 70 is removed.

One of the features of the slip-on type locking mechanism is that withone simple inwardly push the needle 44 is inserted directly into thecenter of the seal 36 and the cap member is locked to the portstructure. Another feature of this connector 71 is that when the tips 76of the clips snap into the groove 78 a "click" sound is made by the tipsstriking the body of the cap member. With repeated use, however, thehinges 75, due to internal stress produced in the nylon material, loosesome of their spring action. Consequently, the tips 76 are not held withsufficient force in the groove 78, nor do they strike the body of thecap member to produce the desired "click" sound. Moreover, the materialwill eventually crack along the flex line of the hinge and a break willoccur. The reliability of this connector 71 is substantially improved bythe third embodiment of this invention which employs a unique lockingmechanism.

THIRD EMBODIMENT OF THE INVENTION

As shown in FIG. 7, the third embodiment of this invention, connector90, includes a sealed port structure 91 and a cap member 92 having alocking mechanism 94 for detachably securing the cap member 92 to theport structure 91. The cap member 92 is similar to the cap members ofthe other embodiments and houses within its cavity 92a (FIG. 8) theneedle 44. The cavity 92a has a tapered side wall 93 to better directthe needle 44 into the center of the seal 36.

The port structure 91 is a tubular conduit 102 having, at one end, areduced diameter nipple 104 over which the seal 36 fits and, at theother end, a tapered barrel 103. The seal 36 is of the same typeemployed in conventional devices such as shown in FIG. 2. Material isremoved from the barrel 103 to reduce cost. This results in theformation of flutes 103a in the barrel 103. At the base of the barrel103, adjacent the end of the port structure 91, is an annular, disk-likepiece which provides a lip 106. When the cap member 92 is placed overthe port structure 91, a handle 96, which is a component of the lockingmechanism 94, engages this lip 106. The handle 96 is hinged to the body98 of the cap member by a two component hinge 100.

As best shown in FIGS. 14 and 15, a hook 114 is one component of thehinge 100 and the other component of the hinge is a crossrod 108 (FIG.18) carried by the handle 96. The hook 114 projects outwardly from thebody 98 of the cap member and has adjacent to it a ramp 116, which asshown in FIG. 18, holds the crossrod 108 when the handle 96 is attachedto the body of the cap member. A section of the crossrod 108 is cut awayto provide a miter slot 118 which engages the ramp 116.

The handle 96 is best shown in FIGS 12 and 13. It has a pair of spacedapart plates 110 and 112 extending downwardly from the underside of thehandle and the crossrod 108 is disposed between these plates, with theopposed ends of the crossrod being integral with the plates. Oppositethe crossrod 108 and parallel to it is a third plate 120, which isintegral with the underside of the handle 96 and is at a right angle toand connects with the forward ends of the plates 110 and 112. Disposedon the underside of the handle 96 between the catch tip 122 and theplate 120 is a clapper bar 126. The clapper bar 126 produces the "click"sound when it strikes the body 98 of the cap member. This clapper bar126 extends away from the plate 120 at a right angle and is integral, atone end of the handle, with the catch tip 122 and, at its opposite end,with the plate 120. The leading edge 124 of the catch tip 122 is beveledto facilitate the slippage of this tip up and over the lip 106 which isalso beveled. At the point where the clapper bar 126 merges with theinside of the catch tip 122, there is a notch 128, which, as shown inFIG. 10, receives the lip 106 when the handle 96 is in the lockingposition. At the rearend of the handle 96 is a leaf spring 130 which hasone end free and its opposed end integral with the handle 96. At thefree end of the leaf spring 130 are two spaced apart tracks 132 and 134(FIG. 12). When the handle 96 is attached to the body of the cap memberas shown in FIGS. 8 through 10, a finger 136 on the body 98 of the capmember is received within the channel 138 between the tracks 132 and134. On the underside of the handle 96 are two downwardly projectingreinforcing strips 140 and 142 (FIG. 12) which provide structurerigidity to the handle.

The way in which the handle 96 is pivotably connected to the cap member92 by the two component hinge 100 is illustrated by FIGS. 16 through 19.To attach this handle 96 to the body 98 of the cap member, first onepositions the handle over the body of the cap member opposite the hook114 and then moves the handle into contact with the cap member so thatthe crossrod 108 touches the rearend of the ramp 116. The spring 130 isdepressed at this time. Next, the handle 96 is moved towards the left,as shown in FIG. 17, with the crossrod 108 sliding up the ramp 116 untilit engages the leading edge 140 of the hood 114. The dimension betweenthe edge 142 of the ramp 116 and the edge 140 of the hook 114 is lessthan the diameter of the crossrod 108. Consequently, the hook 114 mustflex slightly upwardly in a counterclockwise direction, as viewed inFIG. 17, until the crossrod 108 clears the edge 142 of the ramp andsnaps into the position shown in FIG. 18. The hook 114 thus returns tothe unflexed condition shown in FIG. 18, wrapping around the crossrod108. The miter slot 118 then engages the edge 142 of the ramp, with thisedge abutting the junction 118a of the slot 118 (FIG. 18). The ramp 116thus holds the crossrod 108 in position, preventing the handle frombecoming dislodged from the hook 114 and preventing the handle 96 fromtilting to-and-fro about its longitudinal axis. When the handle 96 is somounted to the body 98 of the cap member, the finger 136 slips into thechannel 138 between the tracks 132 and 134 and holds the rearend of thehandle so that it does not tend to move laterally. The handle 96 is,however, free to pivot about the hinge 100.

Unlike the hinges 75 of the second embodiment of this invention, the twocomponent hinge 100 does not break due to fatigue. Thus, in accordancewith one feature of connector 90, the handle 96 may be moved between alocked position (FIG. 10) and unlocked position (FIG. 8) as often as onewishes without breaking. At the same time, the handle 96, coating withthe body 98 of the cap member 92, generates a "click" sound when the capmember is locked to the port structure 91. This "click" sound, as bestillustrated in FIGS. 9 and 10, occurs when the handle 96 moves betweenthe flexed position shown in FIG. 9 and the locked position shown inFIG. 10.

The connector 90 is highly reliable under actual hospital workingconditions, and the way connector 90 is used is best shown in FIGS. 8through 10a. First, the nurse inserts the end of the port structurecarrying the seal 36 into the open mouth 93 of the cap member 92 tobring the lip 106 into engagement with the catch tip 122 of the handle96 as shown in FIG. 8. As this is done, the tapered side wall 93 of thecap member and the tapered barrel 103 slide along each other to directthe needle 44 into the center of the seal 36. Simultaneously, thebeveled edge 124 of the catch tip rides over the beveled lip 106 untilthe lip just engages the underside edge of this tip as shown in FIG. 9.This causes the handle 96 to rotate in a clockwise direction as viewedin FIG. 9, with the crossroad 108 turning while in the grasp of the hook114. There is enough clearance between the miter slot 118 and the edge142 of the ramp to allow the crossrod to turn sufficiently so the catchtip 122 clears the lip 106. Thus the handle 96 pivots about the hinge100, depressing the spring 130. With the handle 96 and lip 106 in thisposition and the spring 130 depressed, as soon as the lip 106 clears theedge of the catch tip 122, the spring rotates the handle in acounterclockwise direction, moving it to the position shown in FIG. 10with ample force so that the clapper bar 126 strikes the body 98 of thecap member to produce the "click" sound. This "click" sound is theaudible signal which the nurse may rely upon to indicate that the capmember 96 is locked to the port structure 91. Under certain hospitalconditions, particularly in the intensive care unit where there is not agreat deal of light, this is an important feature because it providesadditional assurance that the cap member 92 is locked to the portstructure 91.

As shown in FIG. 10, with the handle 96 in this locked position, theneedle 44 has penetrated the central portion of the seal 36, directed bythe tapered sidewalls of the cavity 92a and the barrel 103. Medicationnow flows through the connector 90 into the patient. Note, the handle 96is not depressed as the cap member 92 is slid over the port structure91. To remove the cap member 92, the handle 92 is depressed, moving itto the position shown in FIG. 10a. With the handle 96 in this position,the cap member 92 is pulled off the port structure 91.

Except for the seal 36, the connector 90 is made entirely of atransparent plastic. The use of a transparent plastic is preferredbecause this allows the nurse to see that the needle 44 is correctlyinserted into the seal 36, and thus provides additional safety. Also,the use of plastic makes the connector 90 a low cost, disposable item.The plastic most suitable is a polycarbonate made by Cyrolite.Industries in Azusa, Calif. sold under the tradename Cyrolite. Thisplastic, which is commonly employed to make medical devices, has beenapproved for such uses by the United States Federal Drug Administration.

The connector 90 is particularly adapted to be used in a variety ofdifferent applications. For example, as illustrated in FIG. 20, it maybe connected directly in line with a container 144 of medication to besupplied intravenously to a patient. In this instance, the cap member 92has a tube 146 extending from it which has at its one end a malecomponent 148 of a conventional luer lock connector. This male component148 engages and locks with a mating female luer component 150 attachedto the end of a line 146 extending from the container 144. In a similarmanner, the port structure 91 has extending from it a tube 154 which hasat its end a female luer component 158 of a second luer lock connector.The male component 156 of this second luer lock connector is attached tothe end of a tube 160 that is connected to a needle inserted into thevein of the patient. The luer lock connectors may be obtained fromBurron Medical, Inc, in Bethlehem, Pa.

FIG. 21 illustrates the connector 90 integrated into a conventionalpiggyback connector 162. The branch line 164 from the piggybackconnector 162 has attached to it and integral therewith the portstructure 91 including the lip 106 that engages the catch tip 122 of thelocking mechanism 94. Thus, a conventional feeding system 10 employing apiggyback connector may be modified by simply including a lip 106adjacent the seal 36. This lip 106 will then serve as the site fordetachably connecting the cap member 92 to the piggyback connector 162.

The connector 90, as shown in FIG. 22, also lends itself to be used withcentral venous catheters which are inserted into the chest of thepatient. Frequently, patients under home care use such catheters, andconsequently, even simpler and safer devices and techniques must beemployed. However, a serious problem with such catheters is the way theends of the lumens or tubes 166 and 168 extending from the patient aresealed. Presently, the ends of these tubes 166 and 168 are sealed usingconventional luer locks. When it is time for the patient or the nurse tointroduce medication into the catheter, an intermediate portion of thetubes 166 and 168 must be clamped while being connected to the source ofmedication so that air is not drawn into the blood stream of thepatient. Any large intake of air into the patient's blood stream willseriously injure or even kill the patient. With children, even a smallamount of air may be fatal. That is why clamps are used to close off thetubes 166 and 168 until the connection is made with the source ofmedication. This results in the tubes 166 and 168 wearing out, requiringthat they be repaired. Not only is this a dangerous system, but it isextremely inconvenient for the patient or nurse to use.

As illustrated in FIG. 22, the connector system 90 overcomes thesedifficulties by simply having at each of the respective ends of thetubes 166 and 168 port structures 91. When the patient need medication,he or she simply connects two of the cap members 92 to the respectiveport structures 91, and when finished, disconnects the cap members. Themedication is fed by the needles 44 through the seals 36 and into therespective tubes 166 and 168. The cap members 92, when detached,withdraw the needles 44 from the seals 36, which are self sealing. Thus,the nurse does not need to clamp off the tubes 166 and 168 nor isperiodic repair of the tubes required. Since the seal 36 isself-sealing, upon removal of the cap member 92 there is no danger ofair being drawn through the port structure 91 into the patient's bloodstream. Consequently, connector 90 is both safer and more convenient touse than the conventional central venous catheters.

The connector 90 is also adapted to be used repeatedly without damagingthe seal 36. Thus it is even more suitable for such applications asillustrated in FIG. 22 than conventional devices, because of theaccuracy with which the needle 44 may be repeatedly directed into thecenter of the seal 36. When the needle 44 is repeatedly stuck into andwithdrawn from the seal 36, the seal will have numerous holes in it andbegin to develop a "swiss cheese" like appearance. Eventually, a core iscut away from the seal by several of these holes interconnecting,rendering the seal useless because it is no longer self-sealing.Consequently, the seal would have a very short life. By carefullycontrolling the dimensions of the molds used to make connector 90, thecap member 92 and port structure 91 will be precision made parts.Consequently, with repeated use, the needle 44 will essentially alwayspenetrate the same hole in the seal 36, thus avoiding the "coring"problem.

FOURTH EMBODIMENT OF THE INVENTION

The fourth embodiment of this invention, the connector 170, isillustrated by FIGS. 23 and 24. In connector 170 the port structure 172is similar to that shown in the other embodiments except it has a pairof pins on opposite sides of its body 178 which co-act with J-type slits180 and 182 in the sidewall of a cap member 183 housing the needle 44.These J-type slits 180 and 182 are opposed to each other and provide aguideway for the pins 174 and 176 which slide along these slits as theport structure 172 matingly engages the cap member 183.

To use this connector system 170, the nurse aligns the port structure172 with the open mouth 183a of the cap member so that the pins 174 and176 are in alignment with the entryway to the J-type slits 180 and 182.Then the nurse pushes the port structure 172 into the open mouth 183a,sliding the port structure into the cavity within the cap member 183.The pins 174 and 176 first engage the entryway of the J-type slits 180and 182 and then slide along the slits until they reach the base of theslits. At this point, the nurse twists or rotates the cap member 183 andport structure 172 in counter-rotating directions so that the pins 174and 176 will then slide respectively into the hooks 180a and 182a of theslits and be secured. This embodiment does not provide an audible signalupon locking the cap member 183 to the port structure 172, but is veryeconomical to manufacture.

FUNCTION OF THE CAP MEMBER AND PORT STRUCTURE

As will be appreciated from the above description, the cap memberprovides several functions in a single structure. (We will no longerrefer by number to any one of the components of the invention since weare now discussing in general how the cap member and port structurefunction to provide the attributes of safety and convenience.) First,the cap member surrounds the needle and provides a housing in which theneedle is lodged safely so that needle sticks are avoided. Second,because the needle is so lodged within the housing, if the nurse did,for example, lay the cap member on the patient's bed, the needle wouldnot come into direct contact with the bedding which might be infestedwith harmful bacteria. Thus, this arrangement of the needle deep withinthe cavity in the cap member provides protection for the patient againstbacterial contamination and protection for the nurse against accidentalneedle sticks.

The port structure also provides more than one function. First, itserves as the site to attach the cap member, and, by means of a simplelocking element such as a lip, thread, groove, pin or the like, providesan economical way to modify the conventional piggyback connector so thatit may be used with the cap member. Second, the combination of aself-sealing seal and adjacent element that locks with the cap memberprovides a simple way to modify connectors so that they have enhancedsafely and convenience.

The cap member and port structure function in combination to direct theneedle into the center of the seal, lock these pieces together, andenable quick connection. The nurse or patient simply aligns the sealedend of the port structure with the open mouth of the cap member andpushes the two pieces together. The internal wall of the cap member andthe exterior wall of the port structure engage to align the two piecesso that their respective axes coincide, guiding the needle into thecenter of the seal as they are pushed together. Consequently, the needledoes not scrape the inside wall of the port structure so that particlesof plastic are not introduced into the patient's blood stream and thecoring problem is virtually eliminated. The cap member and portstructure each carry elements of a locking mechanism which engage andlock the pieces together when the needle has pierced the seal,preventing accidental disconnect. Although other geometric forms may beemployed, quick connection is facilitated by the cylindricalconfiguration of the walls of the cap member and port structure and thecircular open mouth of the cavity. In particular, the first throughthird embodiments of this invention are very quickly connected becauseno extra step is required to align the cap member and port structure.All that the nurse need do is insert the port structure into the openmouth without any special concern for their relative positions, and,when using the second and third embodiments, simply push these twopieces together until the locking mechanism engages. When using thefirst or fourth embodiments, the extra step of rotating the two piecesrelative to each other is required to engage the locking mechanism. Whenusing the fourth embodiment, the pins must also first be aligned withthe entryways to the J-slits prior to pushing the port structure intothe cavity in the cap member.

Because of the features embodied in the cap member and port structure,this invention may be used under normal hospital conditions withoutcreating any additional work for the nurse, while substantially reducingthe likelihood of harm to the patient due to carelessness and protectingthe nurse against infection and making his or her job easier and faster.

SUMMARY

In summary: Our connector is safe because (a) the needle is recesseddeeply within the cap member and, therefore, is not likely to becontaminated by bacteria, (b) the cap member and port structure uponengagement guide the needle into the center of the seal, avoidingscraping particles from the inside wall of the port structure, (c) thecap member, housing the needle safely within it, protects the nurseagainst needle sticks, and (d) the locking of the cap member and portstructures together prevents accidental disconnects and (e) the "click"signals the nurse when the connector system is locked securely inposition. Our connector is convenient to use because (a) the walls ofthe cap member and port structure, interacting with each other, providea guideway for quick connection, (b) the locking mechanism eliminatesthe burdensome and time consuming task of taping, and (c) the connectoris very simple to use so that it is ideal for home care of patients.

SCOPE OF THE INVENTION

The above description presents the best mode contemplated of carryingout the present invention as depicted by the four embodiments disclosed.The combination of features illustrated by these embodiments provide thesafety and convenience of this invention. This invention is, however,susceptible to modifications and alternate constructions from theembodiments shown in the drawing and described above. Consequently, itis not the intention to limit it to the particular embodimentsdisclosed. On the contrary, the intention is to cover all modificationsand alternate constructions falling within the scope of the invention asgenerally expressed by the following claims:

We claim:
 1. A safety connector system for administering a first and asecond fluid to a patient, comprising:a generally Y-shaped piggybackconnector having a first influent fluid line on a first influent sidethereof for administration of said first fluid and a pierceable septumon a branch port on a second influent side thereof for administration ofsaid second fluid, said Y-shaped piggyback connector having a firstlocking element thereon and also having an effluent fluid line on aneffluent side thereof; and a safety connected for securing a secondinfluent fluid line to said branch port, said safety connector having agenerally tubular body with a piercing element disposed therein, saidtubular body adapted to advance over said pierceable septum and therebycause said piercing element to engage said pierceable septum on saidbranch port, said safety connector further comprising a second lockingelement for detachably engaging said first locking element, therebylocking said piercing element and said pierceable septum in fluidcommunication.
 2. The safety connector system of claim 1, wherein saidsecond locking element of said safety connector comprises at least oneJ-type slot in said tubular body.
 3. The safety connector system ofclaim 1, wherein said piercing element of said safety connectorcomprises a needle.
 4. The safety connector system of claim 2, whereinsaid first locking element on said Y-shaped piggyback connectorcomprises at least one pin on said branch port of said Y-shapedpiggyback connector.
 5. A safety connector system for infusing a firstfluid and a second fluid into a patient, comprising:a piggybackconnector of the type having a first locking element, a first fluidinput cavity, an input side port having a pierceable seal thereon forreceiving said second fluid, and an effluent cavity; and a safetyconnector comprising a generally tubular guard member housing a piercingelement disposed therein adapted to pierce said pierceable seal on saidinput side port, said guard member adapted to be advanceable over saidpierceable seal such that said piercing element penetrates saidpierceable seal to allow a source of fluid to flow through said safetyconnector and into said piggyback connector, said safety connectorfurther comprising a second locking element thereon for engaging saidfirst locking element and locking said safety connector to saidpiggyback connector.
 6. The safety connector system of claim 5, whereinsaid second locking element comprises at least one J-type slot in saidguard member of said safety connector.
 7. The safety connector system ofclaim 5, wherein said guard member of said safety connector comprises atubular wall disposed concentrically about said piercing element andextending axially beyond the tip of said piercing element.
 8. The safetyconnector system of claim 6, wherein said first locking elementcomprises at least one pin on said input side port.
 9. The safetyconnector system of claim 5, wherein said piercing element of saidsafety connector comprises a needle.
 10. A safety connector system foradministering medication intravenously to a patient, comprising:a portelement having first, second and third ends, said first end of said portelement having a pierceable seal thereon, said second end of said portelement being in fluid communication with a first source of fluid andsaid third end of said port element for fluid communication with apatient, said port element having a first locking element thereon; and acap member having a cavity therein, said cavity containing a piercingelement adapted to engage said pierceable seal of said first end of saidport element when said first end of said port element is inserted intosaid cap member, said cap member further comprising a second lockingelement for removably engaging said cap member and said port elementsuch that said first end of said port element may be secured within saidcavity of said cap member when said second locking element and saidfirst locking element are engaged.
 11. The safety connector system ofclaim 10, wherein said cavity of said cap member has an open mouth. 12.The safety connector system of claim 10, wherein said cap membercomprises a tubular body.
 13. The safety connector system of claim 10,wherein said second locking element comprises at least one J-type slotin a side wall of said cap member.
 14. The safety connector system ofclaim 13, wherein said first locking element of said port elementcomprises at least one pin on said first end of said port element forengagement with said J-type slot.
 15. The safety connector system ofclaim 11, wherein said cap member conforms to the shape of said firstend of said port element such that said first end of said port elementcan be guided into said cavity of said cap member through said openmouth.
 16. The safety connector system of claim 10, wherein saidpiercing element comprises a needle.
 17. The safety connector system ofclaim 10, wherein said cap member is detachably locked to said portelement through rotation of said cap member relative to said portelement.
 18. A safety connector system for providing medication from tworemote sources through tubing to a patient, comprising:a Y-shapedpiggyback connector having a first, second and third end and a firstlocking structure, said first end being a port with a pierceable sealthereon for engagement with a safety connector that is connected to afirst source of fluid, said second end being in fluid communication witha second source of fluid, and said third end for fluid communicationwith a patient, said pierceable seal designed to be penetrated by apiercing element on said safety connector; and a safety connector havinga housing with a piercing element disposed therein, said piercingelement being in fluid communication with said first source of fluid,said housing adapted to detachably engage said port such that saidpiercing element penetrates said pierceable seal when said port and saidhousing are engaged, said piercing element being disposed within acavity of said housing and said cavity having an open mouth forreceiving said port, said housing further comprising a second lockingelement to detachably secure said second locking element to said firstlocking element.
 19. The safety connector system of claim 18, whereinsaid second locking element on said housing comprises at least oneJ-type slot in the side wall of said housing.
 20. The safety connectorsystem of claim 19, wherein said first locking element of said piggybackconnector comprises at least one pin on said first end of said piggybackconnector.
 21. The safety connector system of claim 18, wherein saidpierceable seal is of the self-sealing type so that a hole in saidpierceable seal produced by penetration of said piercing element isclosed off upon withdrawal of said piercing element from said pierceableseal.
 22. The safety connector system of claim 18, wherein said housingsubstantially surrounds and extends beyond a tip of said piercingelement.